Safety and feasibility assessment of biodegradable poly ( l-lactic acid/ε-caprolactone) membrane for guided bone regeneration: A case series of first-in-human pilot study

摘要

Background/purposeGuided bone regeneration (GBR) is the most popular technique for alveolar ridge augmentation in implant dentistry, and resorbable cell barrier membrane, made of collagen, is widely used. We tried to develop a new resorbable cell barrier membrane from an animal-free product. This study aimed to investigate the safety and feasibility for clinical application of poly (l-lactic acid/ε-caprolactone) [P (LA/CL)] membrane, a novel biodegradable synthetic material used for GBR.Materials and methodsPatients who required horizontal bone augmentation (≥3?mm implant exposure) for implant treatment were included in the study. P (LA/CL) membrane was used simultaneously with implant placement to achieve bone augmentation by GBR. The occurrence of adverse events was assessed until the follow-up period of a second surgical procedure. The amount of bone augmentation was assessed by means of cone-beam computed tomography, and implant stability was assessed by measuring the implant stability quotient (ISQ). Student'st-test was used and the level of significance was set at p?